ALPRAZOLAM EXTENDED RELEASE- alprazolam tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)

Available from:

Actavis Pharma, Inc.

INN (International Name):

ALPRAZOLAM

Composition:

ALPRAZOLAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions (6.2)]. -   taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.5), Warnings and Precautions (5.5), Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam extended-release tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines lat

Product summary:

Alprazolam extended-release tablets, USP are available as follows: 0.5 mg : Each white to off-white, round tablet imprinted with  on one side and 83 on the other contains 0.5 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3083-06). 1 mg : Each yellow, round tablet imprinted with on one side and 84 on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3084-06). 2 mg : Each peach, round tablet imprinted with  on one side and 87 on the other contains 2 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3087-06). 3 mg : Each light green, round tablet imprinted with  on one side and 86 on the other contains 3 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3086-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Alprazolam (al pra' zoe lam)
Extended-Release Tablets, C-IV
What is the most important information I should know about alprazolam
extended-release tablets?
•
Alprazolam extended-release tablets are a benzodiazepine medicine.
Taking benzodiazepines with opioid medicines, alcohol, or other
central
nervous system (CNS) depressants (including street drugs) can cause
severe drowsiness, breathing problems (respiratory depression), coma
and
death. Get emergency help right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
alprazolam extended-release tablets with opioids affect you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines including alprazolam
extended-release
tablets which can lead to overdose and serious side effects including
coma and death.
•
Serious side effects including coma and death have happened in people
who have abused or misused benzodiazepines, including alprazolam
extended-release tablets. These serious side effects may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty
breathing. Call your healthcare provider or go to the nearest hospital
emergency room right away if you get any of these serious side
effects.
•
You can develop an addiction even if you take alprazolam
extended-release tablets as prescribed by your healthcare provider.
•
Take alprazolam extended-release tablets exactly as your healthcare
provider prescribed.
•
Do not share your alprazolam extended-release tablets with other
people.
•
Keep alprazolam extended-release tablets in a safe place and away from
children.
•
Physical dependence and withdrawal reactions. Alprazolam
extended-release tablets can cause physical dependence an

Summary of Product characteristics

ALPRAZOLAM EXTENDED RELEASE- ALPRAZOLAM TABLET, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALPRAZOLAM EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ALPRAZOLAM
EXTENDED-RELEASE TABLETS.
ALPRAZOLAM EXTENDED-RELEASE TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1981
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT
PRESCRIBING OF THESE
DRUGS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE
INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS
FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. (5.1, 7.1)
THE USE OF BENZODIAZEPINES, INCLUDING ALPRAZOLAM EXTENDED-RELEASE
TABLETS,
EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD
TO OVERDOSE
OR DEATH. BEFORE PRESCRIBING ALPRAZOLAM EXTENDED-RELEASE TABLETS AND
THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION. (5.2) ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF ALPRAZOLAM
EXTENDED-RELEASE
TABLETS AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH CAN
BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A
GRADUAL TAPER
TO DISCONTINUE ALPRAZOLAM EXTENDED-RELEASE TABLETS OR REDUCE THE
DOSAGE. (2.2, 5.3)
RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 1/2023
INDICATIONS AND USAGE
Alprazolam extended-release tablets are a benzodiazepine indicated for
the treatment of panic disorder
with or without agoraphobia, in adults. (1)
DOSAGE AND ADMINISTRATION
Recommended starting oral dosage is 0.5 mg to 1 mg once daily
(preferably in the morning).
Depending on the response, the dose may be increased at intervals